MedTrace Logo

Development and Validation of a Comprehensive Module for Management of Sleep Disorders in ASD Children

NCT06260020 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-02-15

No results posted yet for this study

Summary

Sleep disorder in autism children is common and it affects the physical, behavior and mental health. There is lack of comprehensive management program/module to treat the sleep disorders in children with ASD. Limited studies evaluating the utility of actigraphy to diagnose sleep disorders in ASD and its validation with PSG are present. Rationale of this study is to develop the comprehensive module and validate it for children with autism spectrum disorders, so as to improve the behavioral outcomes as well. This study also helps to utilize actigraphy as a modality to diagnose sleep disorders in children with autism spectrum disorder as performing PSG in these children is cumbersome and difficult as ASD children tend to have sensory abnormalities.

Conditions

Interventions

BEHAVIORAL

Comprehensive module for management of sleep disorders[Behavioral and pharmacological therapy]

Development of module by Delphi method:components of Module include Behavioural intervention Modifying stimulus by change in location,using bedtime stories. Giving schedules to activities which interfere with sleep before bedtime. Using a bedtime pass to allow child to make a prefixed number of requests for parental attention while in bed. Giving sleep items like cuddle toys to replace parental presence. Gradually delaying the bedtime so the child feels urge to sleep. Sleep hygiene by providing suitable environment to sleep, proper bedtime routine, sleep wake schedules Providing rewards for following good bedtime routine as positive reinforcement. Pharmacological intervention Sleep disorders due to underlying ENT, pulmonary conditions, to be treated as per standard protocol Usage of melatonin if required for sleep onset difficulty An 80%agreement over an intervention will be included in the module

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • Sheffali Gulati, MD · All India Institute of Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-20
Primary Completion
2025-06-30
Completion
2025-06-30

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06260020 on ClinicalTrials.gov